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Application Number

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A unique number assigned by Health Authorities to applications which have been submitted by sponsors for review.

Additional Regional Definitions and Synonyms

FDA Application Number This number, also known as the NDA (New Drug Application) number, is assigned by FDA staff to each application for approval to market a new drug in the United States. One drug can have more than one application number if it has different dosage forms or routes of administration

Requesting an Application Number